INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures

NCT05642026 — Phase 4, Recruiting, 180 participants, Zachary Warriner

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The Efficacy of Continuous Intercostal Nerve Blocks in the Treatment of Patients With Multiple Rib Fractures

Registry	NCT05642026
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	180 (Estimated)
Sponsor	Zachary Warriner (Other)
Conditions	Rib Fractures
Interventions	Ropivacaine, Non steroidal anti-inflammatory drug and opioids (Drug)
Dates	start 2025-09-23, primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2022-12-08, last updated 2025-10-07
Locations	1 site in United States

-Summary

This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and oral outpatient) alone for patients with multiple rib fractures. The objective of this study is to analyze the effect of continuous intercostal nerve block (CINB) in the treatment of patients admitted to the adult trauma service with rib fractures. The effectiveness of CINB as adjunctive treatment will be compared to standard medical therapy involving nonsteroidal and intravenous/oral opioid medications.

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+Arms and interventions

Arm	Type	Interventions	Description
continuous intercostal nerve block (CINB)	Experimental	Drug: Ropivacaine; Drug: Non steroidal anti-inflammatory drug and opioids	patients admitted to the adult trauma service with rib fractures who are receiving CINB
standard medical care	Active comparator	Drug: Non steroidal anti-inflammatory drug and opioids	patients admitted to the adult trauma service with rib fractures who are receiving standard medical care

Ropivacaine (Drug), also known as Naropin: Patients in this group will receive CINB (continuous local intercostal infusion of 0.2% Ropivacaine). A single catheter will be placed for short segment involvement and two catheters will be placed in series for longer segments of involvement. If necessary and as part of standard of care, CINB treatment will continue after patient discharge. The administration of CINB therapy will continue in the same manner as inpatient therapy.
Non steroidal anti-inflammatory drug and opioids (Drug): Patients in this group receive nonsteroidal and opioid pain medications (intravenous/oral inpatient and oral outpatient) per standard of care.

+Outcome measures

Primary outcomes

Length of hospital stay [7 days]: time from randomization until the time of discharge

Secondary outcomes

Patient daily pain scores [7 days]: Pain will be assessed using a 10-Point Numerical Pain Scale (as part of standard of care) every day while patient is hospitalized and 2 days following discharge at follow contact. Scores range from 0-10; higher scores indicated higher levels of pain.
Modified Morphine Equivalent (MME) differences [7 days]: Total morphine milligram equivalents (MME) will be assessed
hospital-free days [30 days]: number of outpatient days for 1 month following randomization
spirometry values [7 days]: measurements of inspiratory volume in milliliters will be taken pre-placement, 60 minutes after catheter insertion, the following day, and each subsequent morning
mean respiratory rates [7 days]: number of inspiratory cycles per minute taken each day until the patient is discharged
Patient reported quality of life [7 days]: Patient reported quality of life will be measured through the EuroQol instrument (EQ-5D-5L). The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems."

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Subjects will be at least 18 years old
* Subjects will have 2 or more identified rib fractures
* Subjects will be willing to provide informed consent for procedure
* Subjects will be identified as appropriate for initiation of continuous nerve block therapy for treatment of rib fracture associated pain.

Exclusion Criteria:

* Documented allergy to study medication
* Epidural catheter use
* Prisoners
* Refusal of CINB therapy

+Locations (1)

Facility	City	Country	Status
University of Kentucky Medical Center	Lexington, Kentucky	United States	Recruiting

+Investigators

Zachary Warriner, MD, Principal investigator, University of Kentucky